”Duke Empirical, Inc.  is committed to providing contract engineering and manufacturing services, for the medical device industry, that meet or exceed all defined customer requirements, regulatory requirements, and to maintaining an effective quality management system (QMS).” Duke Empirical maintains an ISO 13485:2003 compliant quality system.  This quality system has been independently certified by KEMA MEDICAL  since March 2003.

The Duke Empirical quality system defines the methods for performing each process performed in association with your product including:

• Contract Review
• Receipt and inspection of materials
• Non-conforming material review and disposition
• Supplier and Purchasing controls
• Process Controls
• Corrective and Preventative Actions
• Calibration and Preventative maintenance of equipment

Design Control: When our customer’s needs dictate, Duke Empirical will guide their design projects through four defined phases of development:

• Definition
• Design and Process Development
• Validation
• Production/build for launch

The output of each phase is a defined set of deliverables, culminating in a Phase Design Review.  The deliverables for each rigorously document every step in the development process, and together comprise the basis for a complete Design History File or Dossier. Duke Empirical maintains controlled copies of our customer’s critical specifications for each product manufactured at Duke Empirical.  Duke Empirical will not make changes to products or processes that affect critical specifications without formal written approval from our customer.
Duke Empirical proudly welcomes our customers to perform on-site audits and inspections of our facility and quality system.  We will provide copies of our Quality Manual and relevant Standard Operating Procedures to our customers upon requests.